Process Validation Engineer

Description: We are seeking a highly motivated and detail-oriented Process Validation Engineer with 1-3 years of experience to join our team. The Process Validation Engineer will be responsible for developing and executing process validation and/or process verification protocols and reports to ensure that manufacturing processes are compliant with regulatory requirements and company standards. This role involves collaborating with cross-functional teams to support continuous improvement and maintenance of validated processes. Responsibilities: • Develop, write, review, and execute process validation/process verification protocols and reports. • Conduct risk assessments and develop validation strategies for new and existing processes. • Analyze and interpret process validation data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements. • Collaborate with Manufacturing, Quality, Design Transfer Operations, and other departments to resolve validation issues and implement corrective actions. • Participate in process optimization and continuous improvement initiatives to enhance quality and efficiency. • Ensure compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements. • Provide training and guidance to manufacturing and quality personnel on validation processes and procedures. • Maintain process validation documentation and ensure traceability and accessibility for audits and inspections. • Other duties as assigned by management. Qualifications: • Bachelor's degree in Engineering, Life Sciences, or a related field. • 1-3 years of experience in process validation within a regulated industry (pharmaceutical, medical device, biotechnology, etc.). • Strong understanding of process validation principles, techniques, and industry standards. • Familiarity with regulatory requirements (FDA, ISO) and Good Manufacturing Practices (GMP). • Excellent analytical, problem-solving, and critical-thinking skills. • Strong written and verbal communication skills. • Ability to work both independently and as part of a multidisciplinary team. • Detail-oriented with strong organizational and time-management skills. • Proficient in Microsoft Office Suite (Word and Excel), Google Workspace Preferred Qualifications: • Experience with statistical analysis software (e.g., Minitab, JMP). • Previous experience in a cleanroom or controlled environment. • Knowledge of Six Sigma or Lean methodologies.

Created: 2026-03-10